BMS nabs EU approval for once-daily HIV combo pill
- EU regulators have approved Evotaz for trreatment of HIV.
- Evotaz is a combination of BMS' Reyataz (atazanavir), a protease inhibitor, and Gilead's Tybost (cobicistat), a pharmacokinetic enhancer. It is intended to be used in adults in combination with other antiretroviral drugs.
- Approval is based on phase III data demonstrating virologic failure rates as low as 6% and 8%, at 48 and 144 weeks, respectively.
The approval of Evotaz could seem like another standard-fare HIV therapeutics story---another combination of antiviral components to treat HIV. Another treatment among a sea of treatments. However, the reality is that even though Evotaz combines two existing drugs, the strength of the phase III data in terms of virologic supression is exciting to anyone who treats patients with HIV. Why? Despite the full range of HIV treatment options, only 25% of patients with HIV are virally suppressed.
HIV continues to represent an ongoing unmet medical need. Although there are innovative, effective treatment options, the constant threat of resistance remains. Evotaz performs in that area: In addition to demonstrating a low rate of virologic failure in clinical trials, there were also zero protease inhibitor mutations.
All told, there are 1.1 million HIV-infected individuals in the U.S. and 2.2 million HIV-infected individuals in the E.U. Among those who are not resistant to protease inhibitors, Evotaz represents an important new treatment option that may help them attain and retain virologic suppression.
- Pharma Times EU approves BMS' once-daily HIV combo pill